A Blog of Members of the Administrative Law and Regulatory Practice Section of the American Bar Association

Friday, March 13, 2015

FDA and EPA Seek Comment on Revising Fish Consumption Advice

by Elisabeth Ulmer

The Food and Drug Administration (“FDA”) and the
Environmental Protection Agency (“EPA”) jointly seek comment
on the substance and structure of their updated advice regarding the safety of
eating fish.This draft update will
include “both advice and supplemental questions and answers for those who want
to understand the advice in greater detail.”

In 2004, the FDA and EPA released a document named,
“What You Need to Know About Mercury in Fish and Shellfish,” to assist the
public in reaping the health benefits of eating fish, while reducing mercury
exposure.Fish (which includes both fish
and shellfish) contain protein, omega-3 fatty acids, and many micronutrients,
and are low in saturated fat, but they also contain methylmercury, a form of
mercury that can harm the central nervous system and the developing brain of
fetuses.

The
FDA and EPA now propose to update this 2004 advice in order to align it with
the Dietary Guidelines for Americans 2010.”The FDA drafted its assessment in 2009 and recently modified it after
receiving comments and advice from peer reviewers, the public, and federal
agencies, including the EPA.Although
these recommendations are directed toward a target audience of women who are
pregnant, may become pregnant, or are breastfeeding, this information is intended
for the public at large as well.

The
updated advice from FDA and EPA includes the following four recommendations for
the target audience.First, these women
should consume at least 8 and up to 12 ounces (2 or 3 servings) per week “of a
variety of fish lower in mercury within their calorie needs.”Second, they should avoid tilefish from the
Gulf of Mexico, shark, swordfish, and king mackerel because these four fish
contain the highest mercury concentrations.Third, they should eat no more than 6 ounces of white (albacore) tuna
per week.

Fourth,
as the 2004 FDA guidelines advised, those who eat local fish caught by family
and friends should follow “locally posted fish advisories regarding safe
catch.”Although the amount of mercury
in local waters is unknown, the levels tend to be higher in local fish than in
commercially available fish.In the
absence of such advisories, consumers of locally caught fish should eat no more
than 6 ounces per week and refrain from consuming any other fish in the same
week.In addition, given the continued
development of their nervous systems, the FDA and EPA recommend that children
eat less fish than adult women.

Furthermore,
the FDA and EPA wish to solicit comments regarding ways to change the substance and structure of their updated advice in order to make
the recommendations “both understandable and influential.” The agencies also invite comment regarding whether
to add orange roughy and marlin to the list of fish that both young children
and the target audience of women who are pregnant, may become pregnant, or are
breastfeeding should avoid.These two
fish contain less mercury than the aforementioned four fish that the target
audience should avoid, but orange roughy and marlin contain more mercury than
“nearly all other commercial fish” and “can be unusually low in omega-3 fatty
acids.”Thus, their benefits do not
outweigh the costs.

Finally,
the FDA and EPA seek public comment on the following:

1. Whether the
final updated advice should track the Dietary Guidelines for Americans 2010
more or less closely than the draft of that updated advice now does.

2. Any new science
that has become available since the Dietary Guidelines for Americans 2010 were
issued that would be relevant to the updated advice.

3. Information upon
which to base advice on young children's fish consumption. There have been a
number of studies that have examined the effects of both postnatal exposure to
mercury as well as postnatal fish consumption by young children, but this
research has not been as extensive as the research on prenatal exposures and
maternal fish consumption.

4. As stated
previously, suggestions for improving the clarity and utility of the advice.

5. How to integrate
advice from local advisories for those who consume fish from local streams,
rivers, and lakes.

In
addition to inviting comments, the FDA and EPA will hold a public meeting, in
which the FDA Advisory Committee on Risk Communication will offer its thoughts
on the updated advice.The agencies will
also publish information in the Federal Register about other public meetings
that they plan to host around the country.

The
comment period will close 30 days after the transcripts of the aforementioned
meetings are published. The closure date will be published in a Federal
Register notice.Interested parties are invited to submit comments by any of the
following methods: